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FDA 510(k)

SURGICAL OBTURATOR WITH SEAL

K-Number: K911730 · 1991-12-23

ApplicantApplied Vascular Devices, Inc.
Decision Date1991-12-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGICAL OBTURATOR WITH SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Applied Vascular Devices, Inc.. It received FDA 510(k) clearance on 1991-12-23 under 510(k) number K911730. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL OBTURATOR WITH SEAL?

SURGICAL OBTURATOR WITH SEAL is a medical device that received FDA 510(k) clearance on 1991-12-23. The listed applicant is Applied Vascular Devices, Inc.. The 510(k) number is K911730.

When did SURGICAL OBTURATOR WITH SEAL receive FDA 510(k) clearance?

SURGICAL OBTURATOR WITH SEAL received FDA 510(k) clearance on 1991-12-23, under 510(k) number K911730.

Who is the listed applicant for SURGICAL OBTURATOR WITH SEAL?

The FDA 510(k) record lists Applied Vascular Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL OBTURATOR WITH SEAL?

The FDA product code for SURGICAL OBTURATOR WITH SEAL is GCJ.

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Other records listing Applied Vascular Devices, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K911589DISPOSABLE SURGICAL TROCAR WITH SEALK910339AVD INTIMAX OCCLUSION CATHETERK910372INTIMAX THROMBECTOMY CATHETERK911181INTIMAX(TM) IRRIGATION CATHETERK910493AVD INTIMAX CHOLANGIOGRAPHY CATHETERK903848DIAGNOSTIC INTRASCULAR CATHETER

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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